NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1477Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1477Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-1477-0500901477001 KIT in 1 KIT (50090-1477-0)Marketed from Nov 28, 2014

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Alyacen 1/35
Generic name (nonproprietary)
norethindrone and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091634
Marketing start
Listing expires
Identifiers
Product ID 50090-1477_0d2b87a8-0799-4985-af1d-1aab0085e39dSPL ID 0d2b87a8-0799-4985-af1d-1aab0085e39dSPL set ID a45ee86e-69ca-49a5-8990-5dde52d4a522RxCUI 312033, 748797, 749858, 1242786

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N450090147700 followed by a unit qualifier and the quantity

Package 50090-1477-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091634

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091634
ProductStrengthForm · routeLabelerProduct NDC
Alyacen 1/35norethindrone and ethinyl estradiol—KitProficient Rx LP71205-547
Alyacen 1/35norethindrone and ethinyl estradiol—KitGlenmark Pharmaceuticals Inc., USA68462-394

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